21 results · 31ms · Sources: EU EUDAMED, US FDA

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InnoSEAL Hemostatic Pad

FDA 510(k)
FDA Unclassified ·Unknown

OSS™ Orthopedic Salvage System

FDA UDI
Biomet Orthopedics, LLC·00880304250789·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694040730·PrimaLIF LLIF 13mm x 22mm Lordotic Trial

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613045296·Vented Instrument Guards, Solid Green Radiopaqu...

Mui Scientific

FDA UDI
H & A Mui Enterprises Inc·10678467505351·CUSTOMIZED SINGLE-USE COLONIC 16CH CATHETER

MODIFICATION TO SCINTRON IV

FDA 510(k)
FDA Class 2 ·Radiology

PLAYTEX EMBRACE PETITE BREAST PUMP

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CARELINK

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

CONSTELLATION WITH LASER

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 17, 2011

G7 HI-WALL ARCOMXL LNR 36MM F

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·April 3, 2024

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·August 12, 2020

OHICHO3

FDA Adverse Event
Injury ·Product code LIT·July 19, 2019

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·August 14, 2020

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·September 30, 2020

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·May 28, 2020

OHICHO3

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·September 26, 2018

OHICHO3

FDA Adverse Event
Injury ·Product code LIT·September 17, 2019

BELLAFILL DERMAL FILLER

FDA Adverse Event
Injury ·SUNEVA MEDICAL, INC.·Product code LMH·June 18, 2021

Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the monitor.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·June 11, 2014